scope:

Inclusions

This standard specifies requirements and provides guidance on selecting approaches to establish assurance of sterility for a health care product labelled as "sterile." Approaches to assurance of sterility include terminal sterilization at the accepted SAL appropriate for the product (e.g., 10^-6 or 10^-3), terminal sterilization at alternative SALs and aseptic processing.

This standard as it pertains to terminal sterilization applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means.

Exclusions

This standard does not address health care products that are not labeled "sterile." For example, nonsterile health care products that possess antimicrobial properties or contain preservatives for the control of microbial levels are not addressed.

This standard is not applicable to the sterilization of used or reprocessed health care products.

This standard is not applicable to sterilization of health care products by filtration.

This standard does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

NOTE-See also ISO 22442-1, ISO 22442-2 and ISO 22442-3.

This standard does not attempt to define what is considered an acceptable level of risk to justify an alternative SAL. This risk assessment must be based on valid clinical and/or scientific data. As such, what is considered an acceptable level of risk might vary from product to product.